Ampule for packaging and transferring a liquid or a powder for medical use

ABSTRACT

The invention concerns an ampule comprising a tubular body ( 2 ) made of synthetic material having two chambers ( 3, 4 ) tightly isolated by a membrane ( 9 ) capable of being perforated or a removable or frangible wall, one ( 31 ) of which contains the liquid or the powder ( 6 ), and the other is accessible from outside to be connected during transfer, the frangible membrane ( 9 ) or wall being arranged at the end of a tube ( 8 ) integral with the ampule and emerging into the chamber ( 4 ) capable of communication with outside, said tube ( 8 ) containing a tubular element ( 14 ) having a pointed tip ( 17 ) oriented towards the membrane. The tubular element ( 14 ) and the tube ( 8 ) comprise means ( 13, 16 ) preventing the tubular element ( 14 ) from being separated from the tube ( 8 ) after one has been mounted into the other.

The subject of the present invention is an ampule for packaging andtransferring a liquid or a powder, for medical use, in a container.

Devices exist for transferring a liquid stored in a sealed container toa drip bag or for transferring a freeze-dried or other type of powder,once it has been reconstituted into liquid form, to a drip bag.

Drip bags are generally equipped with an injection site formed of a tubeconnected to the contents of the bag and closed by a puncturable film orby a valve device. Valve devices are generally housed in the end of afemale LUER Lock hub. The valve opens automatically when a male LUERLock is connected.

The existing devices are intended to improve patient safety by reducingthe risks of bacteriological contamination, and to improve operatorsafety by reducing the risks of needle-stick injuries and the inhalationof toxic products.

The existing devices are all in the form of a preassembled system forclipping onto a standard-size glass bottle equipped with a stopper,puncturable or otherwise, depending on the device.

The use of glass bottles entails specific operating means, and leads toa high cost. Furthermore, the use of glass poses a problem because ofthe risk of breakage, which may have serious consequences when themedicinal product is dangerous, as is the case of medicinal productsused to treat cancer.

Document FR 2 791 254 in the name of the Applicant describes an ampulefor packaging a liquid for medical use. That device comprises a needleof the hypodermic type, the point of which faces toward a puncturablemembrane and the other end of which is equipped with means of connectionto a medical syringe. That device can be used only in conjunction with asyringe.

Now, in a certain number of medical applications, there is no need tometer out drugs aspirated from the ampule and seen against thegraduations of the syringe, particularly when the issue is one oftransferring the entire contents of an ampule to a drip bag.

The object of the invention is therefore to provide an ampule forpackaging and transferring a liquid or a powder into a bag for medicaluse, which is self-sufficient and does not require the use of anintermediate syringe. The ampule according to the invention needs to bean ampule of simple structure, entailing no use of means other thanthose contained in the ampule, and affording complete safety to patientsand operators, by, in particular, preventing certain constituent partsof the ampule from being able, while the liquid or the powder is beingtransferred, or after the liquid or the powder has been transferred, tocontaminate the patients or care staff.

To this end, the ampule to which it relates, comprising a tubular bodymade of synthetic material having two chambers isolated in a sealedmanner by a puncturable membrane or a removable or frangible wall, oneof which chambers contains the liquid or powder and the other of whichchambers is accessible from the outside to establish a connection at thetime of transfer, the puncturable wall or membrane being arranged at theend of a tube secured to the ampule and opening into the chamber, whichcan be placed in communication with the outside, this tube containing atubular element having a pointed end facing toward the membrane andbeing movable over a distance at least equal to that necessary topuncture the membrane, is characterized in that the tubular element andthe tube comprise means preventing the tubular element and the tube frombeing separated once one has been mounted in the other. As the ampule ismade from synthetic material, the risks of its breaking are excluded.Furthermore, the ampule incorporates the means for transferring to abag, these means consisting of the tubular element mounted to slide inthe tube that the ampule comprises. The use of this ampule avoids anyrisk to the medical staff, because the tubular element cannot beseparated from the tube once it has been mounted in the latter.

According to one feature of the invention, the means preventing thetubular element and the tube from being separated consist of a shoulderformed at the periphery of the tubular element and at least oneprojecting part formed on the internal face of the tube. Advantageously,the tubular element and the tube are each equipped with an annularshoulder forming the separation-preventing means. The annular shoulderof the tubular element also provides sealing with respect to the tube,once the membrane has been punctured.

This separation of the tubular element from the tube can be obtainedbefore or after the membrane has been punctured, the essential pointbeing that the tubular element cannot be separated from the tube oncethe product has been transferred.

In order to improve the robustness of the tubular element and the sealbetween the tubular element and the tube, the part of the tubularelement situated toward the pointed end is of frustoconical shape,complementing that of the corresponding part of the tube, in which partthe tubular element is engaged in the position in which the membrane hasbeen punctured.

There are various possible forms of embodiment of this ampule.

According to a first embodiment, the second end of the tubular elementis also pointed.

Advantageously, in this case, the tubular element comprises, toward itssecond end, a part that, in the storage position, protrudes beyond thetube by an amount at least equal to the amount by which the tubularelement moves.

According to another embodiment of this ampule, the second end of thetubular element is in the form of a coupling, such as a male LUER hub.

To make connection to a bag easier, the tube has an internal screwthread for a threaded coupling intended to be fixed with sealing ontothe second end of the tubular element.

To prevent the tubular element and the tube from turning while theconnection is being made, the tubular element and the tube comprisecomplementary rotation-proofing fins.

According to another embodiment of this ampule, the region of the tubelocated away from that equipped with the membrane is shaped as acoupling of the female LUER type.

Advantageously, in this case, and in order to ensure a good coupling ofthe container to the ampule, this end of the tube has an external screwthread for an internally threaded coupling intended to be fixed withsealing onto the tube and comprising an internal part in the form of aLUER hub, engaged in the tube and resting against the end of the tubularelement.

According to one feature of the invention, the chamber not containingthe liquid or the powder is closed. This closure may be achieved using apeelable film or using a cap.

According to another embodiment of this ampule, the ampule is made offlexible synthetic material and the chamber containing the liquid or thepowder is closed by flattening and heat-sealing.

According to another embodiment of this ampule, the ampule is made ofrigid synthetic material and the chamber containing the liquid or thepowder is closed by an attached stopper.

The stopper may also be produced in the form of a container for themedicinal product. The heat-sealing weld in this case will be offsettoward the central part of the body.

According to one embodiment of this ampule, when the end region of thetube at the opposite end from that equipped with the membrane is shapedas a coupling of the female LUER type, this end of the tube has anexternal screw thread for an internally threaded coupling intended to befixed with sealing onto the tube and comprising an internal part in theform of a LUER hub, engaged in the tube and resting against the end ofthe tubular element.

This last embodiment allows fitting to any type of container,particularly glass bottles or injection sites that are not fixed at theend of a tube.

In any event, the invention will be clearly understood with the aid ofthe description that follows, with reference to the attached schematicdrawings that, by way of nonlimiting examples, depict severalembodiments of this ampule.

FIG. 1 is a view in longitudinal section of a first ampule.

FIGS. 2 to 5 are part views in longitudinal section of the same ampuleduring several successive phases of use.

FIGS. 6 to 8 are three views of an alternative form of embodiment of theampule of FIGS. 1 to 5, during three phases of use.

FIGS. 9 to 13 are five views of another ampule in the course of fivephases of use.

FIGS. 14 to 17 are four views in longitudinal section of another ampule,during four phases of use.

The ampule depicted in FIG. 1 comprises a cylindrical tubular body 2made of synthetic material, having two chambers, a lower chamber 3 andan upper chamber 4, separated from one another by a partition 5 in theform of a disk. The chamber 3 contains a product such as a liquid or apowder 6 and is closed off by an end wall 7 fixed, for example, by heatwelding. Extending from the partition 5 is a tube 8 that is closed offnear the partition 5 by a puncturable membrane 9. The tube 8 on itsinterior face and near the membrane 9 comprises a frustoconical part 10extended by a tubular part comprising an annular recess 12 bounded, nearthe free end of the tube, by an annular shoulder 13. Associated with thetube 8 is a tubular element 14 comprising a front part 15 offrustoconical shape, complementing the frustoconical part 10 of the tubeand a peripheral annular shoulder 16 intended to bear with sealing inthe annular recess 12 and to come into abutment against the shoulder 13of the tube to prevent any risk of the tubular element being extracted.This tubular element has two points 17 and 18 facing one toward themembrane and the other toward the outside. In the embodiment depicted inthe drawing, when the point 17 is set back from the membrane 9, as shownin FIG. 1, the tubular element 14 cannot be extracted from the tubebecause the shoulders 16 and 13 are resting against each other. Thechamber 4 is closed off by a peelable film 19.

A connection is intended to be made with a bag 20, just part of which isdepicted in the drawing, ending in a nozzle 22 equipped with a fillingsite 23 equipped with a puncturable stopper 24.

The use of the ampule depicted in FIGS. 1 to 5 is as follows:

The film 19 is torn off. The point 18 of the tubular element 14 isoffered up to the center of the stopper 24 of the bag 20. If the stopperof the injection site of the bag is easy to puncture, the point 18 willpuncture it before the point 17 punctures the membrane 9 of the ampule.However, liquid cannot flow out because of the sealing means 16. Withthe pressure sustained, the end of the injection site 22, 23 will comeup close to the part of the tubular element 14 protruding from the tube8. The tubular element will then puncture the membrane 9 to make thecommunication between the two volumes. This is the position depicted inFIG. 4. The operator then exerts presses repeatedly on the flexible bag,allowing the liquid to flow from the bag to the ampule and the aircontained in the ampule to flow into the bag. If the ampule containspowder, the powder can thus be dissolved in the liquid thus taken up.When the powder is fully dissolved, the operator inverts the assembly,the ampule being at the top and the bag at the bottom, and resumes thepumping action by pressing successively on the flexible bag. The liquidcontained in the ampule passes into the bag and is replaced with the aircontained in the latter. Once the operation is over, the operatoruncouples the bag and the ampule, the tubular element 14 remainingcaptive in the ampule, thus avoiding any risk of contamination.

If the ampule contains a medicinal product in liquid form, only thesecond operation need be performed in order to transfer the liquid tothe bag.

In the embodiment depicted in FIGS. 6 to 8, in which the same elementsare denoted by the same references as previously, the tube 8 protrudesbeyond the second chamber 4. In the position of non-use, the ampule isclosed by a cap 25. In this embodiment, a second tube 26 is mounted toslide on the first tube 8. The end of this second tube 26 may be closedoff by a stopper 27.

This ampule is aimed essentially at transferring the contents of theampule to a bottle 28 that is not equipped with a connecting tube but issimply closed by a puncturable stopper 29.

In this case, the operator, having removed the protective cap 25,presses the stopper 27 against the stopper 29 of the bottle. With theampule held by the operator, pressure is exerted toward the bottle 28 tocause the tube 26 to slide on the tube 8, thus allowing the point 18 topuncture the stoppers 27 and 29 in succession, and allowing the point 17to puncture the membrane 9. This is depicted in FIG. 7. As the contentsof the ampule are in communication with the contents of the bottle or ofthe bag, reconstitution can be performed in the way indicatedpreviously, the pumping action being performed by the ampule.

At the end of the procedure, the operator pulls on the body of theampule, holding the tube 26 still, and this has the effect of causingthe tube 26 to cover the point 18 and then of locking this tube throughthe collaboration of a shoulder 30 of the tube 26 with a groove 32 ofthe tube 8, as shown in FIG. 8. The needle is thus protected after use.If the membrane 27 is chosen to be of a self-sealing material, thechamber 3 is isolated in a sealed manner from the outside, thus avoidingharmful emanations when the medicinal product is dangerous to the carestaff.

As a preference, and as is the case in the two embodiments mentionedhereinabove, the ampule comprises protective means preventing the userfrom accessing the point 18, so as to avoid any injury or contamination.In the first embodiment mentioned, protection is afforded by the tubularbody 2 forming the second chamber 4, which surrounds and protrudesbeyond the point 18, even when the element 8 is in the high position andthe shoulders 13 and 16 are in abutment against each other, asillustrated in FIG. 5. In the second embodiment, the protective meansare formed by the protective tube 26 that covers the transfer element,particularly the point 18, at all times, except when a bottle or a bagis connected to the ampule, as is illustrated in FIGS. 6, 7, and 8.

FIGS. 9 through 13 depict another embodiment in which the same elementsare denoted by the same references as previously.

In this embodiment, the end of the tubular element 14, the opposite endfrom the point 17, consists of a male LUER hub 35. The rear end of thetube 8 has a screw thread 36. The front end of the tubular element 14has fins 37 complementing fins 38 formed in the tube 8 near the membrane9. These fins are aimed at preventing the tubular element from turningwith respect to the tube in the position in which the membrane has beenperforated. In the embodiment depicted, a bag 39 is equipped with a site40 with a valve associated with a female LUER hub 42 intended to engagewith the male LUER hub of the tubular element.

This ampule is used as follows:

Having torn off the film 19, the site 42 of the bag 39 is engaged on theLUER hub 35 of the element 14, and screwed into the internal screwthread 36 of the tube 8. This connecting movement is depicted in FIG. 2,where the membrane is punctured first of all. It is also possible toimagine the scenario where coupling between the bag and the tubularelement is achieved before the membrane is punctured, as shown in FIG.11. FIG. 12 shows the ampule and the bag in the connected position, fromwhich position transfer of the liquid or powder from one container tothe other can be achieved in the way mentioned earlier.

At the end of the transfer, and as shown in FIG. 13, the bag isdisconnected, having been unscrewed from its site, the tubular element14 remaining held in the tube 8, as shown in FIG. 13.

FIGS. 14 to 17 depict another form of embodiment of this ampule in whichembodiment the same elements are denoted by the same references aspreviously.

In this case, the outer end of the tube 8 is shaped as a female LUER hub35 able to accommodate, with sealing, a male LUER hub 46 of a container47 or of a syringe, bearing with sealing against the posterior end ofthe tubular element 14. To provide conditions for connection, the tube 8may have an external screw thread 48 onto which an internally threadedpart 49 belonging to the neck of the container 47 is screwed.

As the neck is screwed onto the tube 8, the female LUER hub 45 and maleLUER hub 46 become coupled and the end of the male LUER hub 46 pushesagainst the tubular element 14 to puncture the membrane 9 as shown inFIG. 15. FIG. 16 depicts the end of connection, from where transfer canbegin. Uncoupling is achieved by unscrewing, as shown in FIG. 17, thetubular element 14 remaining captive in the tube 8.

As is apparent from the foregoing, the invention makes a greatimprovement to the existing art by providing an ampule, intended forpackaging and transferring a liquid or a powder to a bag or anothercontainer, of a simple structure, incorporating the transfer means andretaining these after transfer, thus avoiding the risks of contaminationboth as far as the patient is concerned and as far as the operator isconcerned.

As goes without saying, the invention is not restricted solely to theembodiments of this ampule described hereinabove by way of examples; onthe contrary, it encompasses all alternative forms thereof. Thus, inparticular, the ampule could be made of a flexible synthetic materialand the chamber 3 containing the liquid or the powder could be closedoff not by an end wall but by pinching together the material of whichthe body is made and heat-sealing it, without in any way departing fromthe scope of the invention.

The invention claimed is:
 1. An ampule for packaging and transferring aliquid or a powder for medical use in a container, comprising: a tubularbody made of synthetic material exhibiting two chambers isolated in asealed manner by a puncturable membrane or a removable or frangiblewall, one of which chambers contains the liquid or powder and the otherof which chambers is accessible from the outside to establish aconnection at the time of transfer, wherein the two chambers and thetubular body are one unitary piece; the puncturable wall or membranebeing arranged at the end of a tube secured to the ampule and openinginto the chamber which can be placed in communication with the outside,this tube containing a tubular element having a pointed end facingtoward the membrane and being movable over a distance at least equal tothat necessary to puncture the membrane, wherein the tubular element andthe tube comprise means preventing the tubular element and the tube frombeing separated once one has been mounted in the other and also providessealing between the tubular element and the tube once the membrane hasbeen punctured.
 2. The ampule as claimed in claim 1, wherein the meanspreventing the tubular element and the tube from being separated consistof a shoulder formed at the periphery of the tubular element and atleast one projecting part formed on the internal face of the tube. 3.The ampule as claimed in claim 2, wherein the tubular element and thetube are each equipped with an annular shoulder forming theseparation-preventing means.
 4. The ampule as claimed in claim 2,wherein the means preventing separation are designed to prevent thetubular element and the tube from being separated in the position inwhich the membrane is not punctured.
 5. The ampule as claimed in claim2, wherein the means preventing separation are designed to prevent thetubular element and the tube from being separated in the position inwhich the membrane has been punctured.
 6. The ampule as claimed in claim1, wherein the part of the tubular element situated toward the pointedend is of frustoconical shape, complementing that of the correspondingpart of the tube, in which part the tubular element is engaged in theposition in which the membrane has been punctured.
 7. The ampule asclaimed in claim 1, wherein the tubular element comprises means ofsealing with respect to the tube.
 8. The ampule as claimed in claim 7,wherein the sealing means consist of the means that also hold thetubular element in the tube.
 9. The ampule as claimed in claim 1,wherein the second end of the tubular element is also pointed.
 10. Theampule as claimed in claim 9, wherein the tubular element comprises,toward its second end, a part that, in the storage position, protrudesbeyond the tube by an amount at least equal to the amount by which thetubular element moves.
 11. The ampule as claimed in claim 9, wherein thetube protrudes beyond the chamber not containing the liquid or thepowder and serves to guide the sliding of a second tube covering thepoint of the second end of the tubular element.
 12. The ampule asclaimed in claim 11, wherein the second tube is equipped, at its end,with a membrane or stopper that can be punctured by the second point ofthe tubular element.
 13. The ampule as claimed in claim 9, furthercomprising a protective means preventing the user from accessing thepoint.
 14. The ampule as claimed in claim 13, wherein the protectivemeans are formed by the tubular body forming the second chamber, whichsurrounds and protrudes beyond the point, even when the element is inthe high position and the shoulders are in abutment against each other.15. The ampule as claimed in claim 13, wherein the protective means areformed by the protective tube that covers the point except when a bottleor a bag is connected to the ampule.
 16. The ampule as claimed in claim1, wherein the second end of the tubular element is in the form of acoupling, such as a male LUER hub.
 17. The ampule as claimed in claim16, wherein the tube has an internal screw thread for a threadedcoupling intended to be fixed with sealing onto the second end of thetubular element.
 18. The ampule as claimed in claim 17, wherein thetubular element and the tube have complementary rotation-proofing fins.19. The ampule as claimed in claim 1, wherein a region of the tubelocated away from that equipped with the membrane is shaped as acoupling of the female LUER type.
 20. The ampule as claimed in claim 19,wherein the region of the tube has an external screw thread for aninternally threaded coupling intended to be fixed with sealing onto thetube and comprising an internal part in the form of a LUER hub, engagedin the tube and resting against the end of the tubular element.
 21. Theampule as claimed in claim 1, wherein the chamber not containing theliquid or the powder is closed by a peelable film.
 22. The ampule asclaimed in claim 1, wherein the chamber not containing the liquid or thepowder is closed by a cap.
 23. The ampule as claimed in claim 1, whereinthe ampule is made of flexible synthetic material and the chambercontaining the liquid or the powder is closed by flattening andheat-sealing.
 24. The ampule as claimed in claim 1, wherein the ampuleis made of rigid synthetic material and the chamber containing theliquid or the powder is closed by an attached stopper.